Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients

Phase 2

Completed

• Conditions: Renal Transplantation

• Registration Number: NCT00239902
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney transplant.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Primary Completion: 2004-11
• Study First Submitted: 2005-10-13
• Study First Submitted QC: 2005-10-13
• Study First Posted: 2005-10-17
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-01
• Last Update Posted: 2011-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 396

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
IA, IB, IIA, IIB or III diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant
Permanent resumption of dialysis within 36 months post transplant
Surgical removal of graft within 36 months post transplant
Death within 36 months post transplant
Discontinuation within 36 months post transplant

Secondary Outcome Measures

Name	Time	Method
FEV1 , FVC, DLCO within 36 months post transplant
Serum creatinine and estimated creatinine clearance within 36 months post transplant
Absolute lymphocyte count within 36 months post transplant